COLUMBIA, S.C. — A putative class action has been filed against the makers of the Sorin 3T Heater-Cooler System, accusing the companies of negligently designing the system thereby exposing open chest surgery patients to high levels of a bacteria, which in some cases resulted in a rare, potentially deadly infection.

In a Jan. 23 complaint filed in the District of South Carolina, the plaintiff accuse the defendant manufacturers of failing to adequately test the Sorin 3T System, failing to notify the FDA of design change orders to the system, and failing to warn of patient exposure bacterial colonization.